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OBJECTIVE: The aim of this study is to evaluate the use and acceptability of Carraguard among men and women enrolled as couples in a microbicide trial. MATERIALS AND METHODS: Focus groups were conducted with participants in a 6-month randomized, placebo-controlled trial that enrolled sexually active, low-risk couples in Thailand. Participants were blinded as to which gel they had received at the time of the discussions. RESULTS: Most men and women liked the gel and found it acceptable. The majority of men and women thought that using the gel increased sexual pleasure, although participants disagreed about whether using the gel increased sexual frequency. Drawbacks of gel use included that it was too wet or messy, and nearly all respondents thought that the applicator was too hard. Most men and women questioned the utility of using the gel among married couples since gel use was tied to perception of HIV/STI risk. However, those who perceived themselves to be at risk expressed interest in using the product as an alternative to condoms. Many women were particularly interested in a product that also had contraceptive properties. Gel use also raised issues of trust and fidelity among couples and questions about men's ability to detect women's use of the product. CONCLUSION: Men and women in this study found the gel acceptable and thought that it should be made available if it is found to be safe and effective. Strategies for marketing a potential microbicide product must take the target population into consideration. For married couples, key considerations may be partner dynamics and trust issues, whereas messages focusing on sexual pleasure or disease prevention may resonate more strongly with sex workers or other populations. [ABSTRACT FROM AUTHOR]

The Bangkok Men Who Have Sex With Men (MSM) Cohort Study has shown high HIV incidence (8-12/100 person-years) among 18-21-year-old MSM. These data led to a further study using qualitative methods among young (18-24 years old) MSM in order to understand the factors driving the HIV epidemic among YMSM. We conducted eight focus group discussions and 10 key informant interviews among YMSM in Bangkok, Thailand. Sociodemographic and behavioral data were collected using a questionnaire. We audio-recorded, transcribed, and analyzed qualitative and questionnaire data using computer software. The categories relating to risk behavior were (1) the use of social networks for seeking sexual partners and the marketing promotions of MSM entertainment venues, (2) social influence by peers and older MSM, (3) easy access to high parties and group sex, (4) easy access to club drugs, (5) conceptions related to HIV risk, and (6) sexual preferences of YMSM. Increased HIV testing, same-sex education, and YMSM-specific HIV prevention efforts are urgently needed for YMSM in Bangkok.

Background: High HIV incidence has been detected among men who have sex with men (MSM) in Thailand, but the relationship and timing of HIV, herpes simplex virus 2 (HSV-2), and syphilis is unknown. This analysis measures incidence, temporal relationships, and risk factors for HIV, HSV-2, and syphilis among at-risk MSM in the Bangkok MSM Cohort Study., Methods: Between April 2006 and December 2010, 960 men negative for HIV, HSV-2, and syphilis at entry enrolled and contributed 12-60 months of follow-up data. Behavioral questionnaires were administered at each visit; testing for HIV antibody was performed at each visit, while testing for syphilis and HSV-2 were performed at 12 month intervals. We calculated HIV, HSV-2, and syphilis incidence, assessed risk factors with complementary log-log regression, and among co-infected men, measured temporal relationships between infections with Kaplan-Meier survival analysis and paired t-test., Results: The total number of infections and incidence density for HIV, HSV-2, and syphilis were 159 infections and 4.7 cases/100 PY (95 % Confidence Interval (CI): 4.0-5.4), 128 infections and 4.5/100 PY (95 % CI: 3.9-5.5), and 65 infections and 1.9/100 PY (95 % CI: 1.5-2.5), respectively. Among men acquiring >1 infection during the cohort period, mean time to HIV and HSV-2 infection was similar (2.5 vs. 2.9 years; p = 0.24), while syphilis occurred significantly later following HIV (4.0 vs. 2.8 years, p < 0.01) or HSV-2 (3.8 vs. 2.8 years, p = 0.04) infection. The strongest independent predictor of any single infection in adjusted analysis was acquisition of another infection; risk of syphilis (Adjusted Hazards Ratio (AHR) = 3.49, 95 % CI: 1.89-6.42) or HIV (AHR = 2.26, 95 % CI: 1.47-3.48) acquisition during the cohort was significantly higher among men with incident HSV-2 infection. No single independent behavioral factor was common to HIV, HSV-2, and syphilis acquisition., Conclusion: HIV and HSV-2 incidence was high among this Thai MSM cohort. However, acquisition of HIV and co-infection with either HSV-2 or syphilis was low during the time frame men were in the cohort. Evaluation of behavioral risk factors for these infections suggests different risks and possible different networks.

Background: Vaccination against hepatitis B virus (HBV) is recommended for all HBV-susceptible men who have sex with men (MSM). There is limited information on correlates of immunity to HBV vaccination in this group. We present serologic response rates to hepatitis B vaccine and identify factors associated with impaired response among HIV-uninfected and HIV-infected Thai MSM., Methodology: HBV-susceptible volunteers were offered hepatitis B vaccination at months zero, one, and six. We measured baseline (pre-vaccination) total serum IgG and IgG subclasses (all participants), baseline CD4 count, and plasma HIV-1 viral load (PVL) (HIV+ participants). HBV serologies were retested at 12 months. Serologic responses were compared between all groups in men receiving three vaccine doses., Results: 511/651 HIV-negative and 64/84 HIV-positive participants completed the three-dose series. Response rates in HIV-uninfected and -infected participants were 90.1% vs. 50.0% (p<0.0001). Median pre-vaccination IgG was higher among non-responders than responders overall (1238.9.0 vs. 1057.0mg/dL, p=0.003) and among HIV-infected participants (1534.0 vs. 1244.5mg/dL, p=0.005), but not significantly among HIV-uninfected participants (1105.5 vs. 1054.3mg/dL, p=0.96). Pre-vaccination IgG1 and IgG3 levels were higher among HIV-positive than HIV-negative participants (median 866.0 vs. 520.3, and 105.8 vs. 83.1mg/dL, respectively, p<0.0001). Among HIV-infected participants, median CD4 count in non-responders was 378 cells/μL vs. 431 cells/μL in responders (p=0.20). Median PVL in non-responders was 64,800 copies/mL vs. 15500 copies/mL in responders (p=0.04). Participants with pre-vaccination plasma IgG >1550 mg/dL and PVL >10,000 copies/mL were almost always non-responsive (p<0.01)., Conclusions: HIV infection was associated with poor vaccine responses. High plasma viral load, elevated pre-vaccination total serum IgG and elevated pre-vaccination IgG1 are associated with poorer response to vaccination among HIV-infected MSM. In this group, the combination of high PVL and pre-vaccination total IgG is highly predictive of vaccine failure., (Published by Elsevier Ltd.)

Minimising loss to follow-up is essential to obtain unbiased results. This study aimed to assess factors associated with loss to follow-up and effects on biasing exposure-outcome associations in a cohort of men who have sex with men in Bangkok. We enrolled sexually-active Thai men who have sex with men, at least 18 years old, in a study with four-monthly follow-up visits. At each visit, men answered HIV risk behaviour questions using audio computer-assisted self-interview. Logistic regression was used to evaluate factors associated with loss to follow-up and bias between exposures and prevalent HIV infection were estimated using adjusted relative odds ratios. From 2006 to 2010, we enrolled 1744 men who have sex with men; as of April, 2014, 1256 (72%) had completed at least the month-36 visit; loss to follow-up was 9.6%. Factors independently associated with loss to follow-up were age (18-21 years), education (primary level or less, secondary or vocational education), living outside Bangkok and vicinity, sexual orientation (bisexual, heterosexual), previous HIV testing, HIV infection, and behaviour in the past 4 months (recreational drug use, reporting group sex). An effect of loss to follow-up on factors of prevalent HIV infection was found by sexual orientation (transgender) and unprotected anal intercourse (receptive/insertive). These findings highlight the need to strengthen post-HIV test counselling. Directed counselling for HIV care should be given to young men who have sex with men and recreational drug users., (© The Author(s) 2015.)

This analysis measures prevalence and correlates of consistent lubricant use among a cohort of Thai men who have sex with men (MSM). Lubricant use was queried at the 12-month follow-up visit. Consistent lubricant use was evaluated with logistic regression. Consistent lubricant use was reported by 77.0% of men and was associated with consistent condom use with casual partners, while binge drinking, payment for sex, and inconsistent condom use with casual, and steady, partners were negatively associated. Though consistent lubricant use is common among this Thai MSM cohort, further promotion is needed with MSM engaging in risky sexual practices.

Background: The quadrivalent human papillomavirus (qHPV) and 9 valent (nHPV) vaccine are licensed for males to prevent anal HPV-associated dysplasia and cancer caused by HPV types 6, 11, 16, and 18 (qHPV) and additional types 33, 35, 45, 52, and 58 (nHPV), respectively. Both conditions are common in HIV-infected and HIV-uninfected men who have sex with men (MSM). It is not well documented which anal HPV vaccine types are most prevalent in Southeast Asia., Methods: A convenience sample of 400 anal swabs were obtained from 200 HIV-infected and 200 HIV-uninfected sexually active Bangkok MSM Cohort Study participants. After swab collection in PreservCyt (Cytyc Corp, Marlborough, MA), the media was stored at -80°C until processing. DNA was extracted, amplified by polymerase chain reaction, denatured, and then hybridized to probes for 37 HPV types and β-globin., Results: The mean participant age was 25.6 years (range, 18-55 years); the mean CD4 T-cell count was 410 cells/mm in the HIV-infected participants. Among all swab samples, 386 (192 HIV-positive and 194 HIV-negative) had adequate β-globin for HPV genotype testing. Anal HPV type was detected in 44.3% of participants whose samples underwent genotype testing. Both qHPV and nHPV types were more frequently detected in HIV-infected compared with HIV-uninfected (42.2% vs. 23.2% [P < 0.01], 50.0% vs. 24.2% [P < 0.01]), respectively). There were no significant relationships between social behaviors (alcohol use, drug use) or sexual behaviors (number of partners, condom usage, sexual positioning) and anal HPV prevalence., Conclusions: The prevalence of anal vaccine HPV types in Thai MSM was similar to that reported in MSM from Western populations and has a similar distribution by HIV status. Targeting young MSM with vaccination could offer protection against HPV vaccine types.

Background: Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infection are prevalent among men who have sex with men (MSM) and may infect multiple anatomic sites. We measured site-specific prevalence and correlates of CT and NG infection among Bangkok MSM Cohort Study participants., Methods: In April 2006 to November 2010, 1744 men enrolled in the Bangkok MSM Cohort Study. Participants provided historical information and underwent physical examination. Rectal, urethral, and pharyngeal CT and NG screening were performed by nucleic acid amplification and/or culture. Logistic regression was used to identify correlates of site-specific CT, NG, and coinfection., Results: Among 1743 participants, 19.2% were infected with CT and/or NG. CT, NG, and CT-NG coinfection were detected in 11.6%, 4.6%, and 2.9%, of participants, respectively. Rectal, urethral, and pharyngeal CT infections were detected in 9.5%, 4.5%, and 3.6% of cases. N. gonorrhoeae was present at these sites in 6.1%, 1.8%, and 0.5% of cases. Most infections were asymptomatic (CT: 95.3%, NG: 83.2%). Rectal CT and NG infections were mutually associated (CT: adjusted odds ratio [AOR], 5.4; 95% confidence interval [CI], 3.4-8.7; NG: AOR, 2.4; 95% CI, 1.1-5.2) and independently associated with HIV infection (CT: AOR, 1.6, 95% CI, 1.0-2.4; NG: AOR, 2.0, 95% CI, 1.3-3.1). Numerous behavioral correlates of infection were observed., Conclusions: CT and NG infections are highly prevalent among MSM in Bangkok, most frequently affect the rectum, and are most often asymptomatic. Routine screening of asymptomatic MSM for CT and NG infection should include rectal sampling and focus on men with HIV and a history of other sexually transmitted infections.

In Thailand, new HIV-1 infections are largely concentrated in certain risk groups such as men who have sex with men (MSM), where annual incidence may be as high as 12% per year. The paucity of information on the molecular epidemiology of HIV-1 in Thai MSM limits progress in understanding the epidemic and developing new prevention methods. We evaluated HIV-1 subtypes in seroincident and seroprevalent HIV-1-infected men enrolled in the Bangkok MSM Cohort Study (BMCS) between 2006 and 2011. We characterized HIV-1 subtype in 231 seroprevalent and 194 seroincident subjects using the multihybridization assay (MHA). Apparent dual infections, recombinant strains, and isolates found to be nontypeable by MHA were further characterized by targeted genomic sequencing. Most subjects were infected with HIV-1 CRF01&#95;AE (82%), followed by infections with recombinants (11%, primarily CRF01&#95;AE/B recombinants), subtype B (5%), and dual infections (2%). More than 11 distinct chimeric patterns were observed among CRF01B&#95;AE/B recombinants, most involving recombination within integrase. A significant increase in the proportion of nontypeable strains was observed among seroincident MSM between 2006 and 2011. CRF01&#95;AE and subtype B were the most and least common infecting strains, respectively. The predominance of CRF01&#95;AE among HIV-1 infections in Thai MSM participating in the BMCS parallels trends observed in Thai heterosexuals and injecting drug users. The presence of complex recombinants and a significant rise in nontypeable strains suggest ongoing changes in the genetic makeup of the HIV-1 epidemic in Thailand, which may pose challenges for HIV-1 prevention efforts and vaccine development.

Background: HIV-1 incidence in men who have sex with men (MSM) is often difficult to estimate. We therefore assessed temporal trends in HIV-1 incidence and behavioural risk factors in MSM in Bangkok, Thailand, from 2006 to 2013., Methods: In this observational study, we used data for clients attending the Silom Community Clinic for voluntary counselling and testing (VCT) services and from the Bangkok MSM Cohort Study (BMCS) to investigate trends in HIV incidence per 100 person-years per quarter in both cohorts. During VCT, basic demographic data were gathered at registration. However, no behavioural risk data were gathered. In the BMCS, we gathered demographic and behavioural data at baseline and at regular study visits using audio computer-assisted self-interviewing. Questions were included about potential risk factors such as drug use, sexual practices, and how often condoms were used. We also analysed behavioural risk factors in the BMCS cohort, using a restricted cubic spline function for time., Findings: From 2006 to 2013, 8176 MSM came for VCT; 1999 (24%) clients were initially seronegative and returned for another test. 235 (12%) individuals seroconverted. The overall HIV-1 incidence was 5.5 per 100 person-years (95% CI 4.8-6.3), with an increasing trend (adjusted p=0.02). In the BMCS, 1372 people were seronegative at baseline; 1259 (92%) had more than one follow-up test and 238 (17%) seroconverted. The overall HIV-1 incidence was 5.3 per 100 person-years (95% CI 4.7-6.1), with an increase and then a decline (inverted U-shaped curve, p=0.0001). Individuals aged 21 years and younger were at significantly higher risk of HIV infection than were those aged 30 years and older in the in the VCT (rate ratio 2.29, 95% CI 1.88-2.78, p<0.0001) and BMCS cohorts (1.99, 1.50-2.65, p<0.0001). Overall, drug use (p=0.03), drug use to enhance sex (p=0.0006), use of drugs for erectile dysfunction (p<0.0001), and 100% condom use (p<0.0001) increased over time, whereas the proportion of individuals reporting receptive anal intercourse decreased (p=0.004)., Interpretation: With a sustained high HIV-1 incidence and increasing drug use in MSM in Bangkok, we urgently need innovative and acceptable HIV prevention interventions, especially for young MSM., Funding: US Centers for Disease Control and Prevention., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

The HIV incidence among Thai men who have sex with men (MSM) enrolled in the Bangkok MSM Cohort Study (BMCS) has remained high since its inception in 2006. The purpose of this BMCS analysis was to determine: (1) changes in three HIV-risk behaviors (unprotected anal intercourse (UAI), recreational drug use, and multiple sexual partners i.e., more than four male/transgender partner) over time; and (2) factors associated with each one separately. Thai MSM aged 18 years or older and living in Bangkok were eligible to participate in the BMCS. At each follow-up visit, participants were asked to report their sexual and drug behaviors in the previous 4 months. We conducted a longitudinal analysis using generalized estimating equations logistic regression that included 1,569 MSM who were enrolled from 2006 to 2010 and contributed at least one follow-up visit. For each four-month visit increase, we found a 2, 1, and 1 % decrease in odds for reported UAI, recreational drug use, and multiple sexual partners, respectively. We found significant predictors associated with three HIV-risk behaviors such as binge drinking, participation in group sex, and use of erectile dysfunction drugs. The statistically significant decrease in odds of HIV-risk behaviors among the participants is encouraging; however, continued vigilance is required to address the factors associated with HIV-risk behaviors through currently available interventions reaching MSM.

Rectal microbicides (RMs) hold promise as a HIV prevention method to reduce transmission among men who have sex with men (MSM). To assess RM trial feasibility in Bangkok, we measured prevalence and correlates of willingness to participate among Thai MSM observational cohort participants. Between April 2006 and December 2010, 1744 MSM enrolled in the Bangkok MSM Cohort Study; at 12 months, RM trial participation willingness was measured. We evaluated correlates of RM trial participation willingness using logistic regression analysis. Participants completing the 12-month visit (81.4%, n = 1419) had a mean age of 27.3 years (SD = 6.1), and 65.5% and 86.1% reported having a steady partner or anal intercourse (AI) in the past four months, respectively. Most (79.1%, n = 1123) participants reported willingness to participate in an RM trial, which, in multivariable analysis, was independently associated with insertive only (adjusted odds ratio [AOR] = 3.25, 95% CI: 1.82-5.81) or receptive/versatile role AI (AOR = 3.07, 95% CI: 1.88-5.01), and being paid for sex (AOR = 12.15, 95% CI: 1.67-88.21) in the past four months, and believing that people with AIDS look sick (AOR = 1.92, 95% CI: 1.23-2.98). Of hypothetical RM trial features to increase enrollment likelihood, the most (91.1%) compelling was that the study be approved by the Thai ethics committee, followed by the study site offering evening hours (88.9%). Reasons not to participate were not wanting a rectal examination (29.5%) or fluid collected from the penis or anus (24.6%) and not wanting the placebo (23.0%). RM trial participation willingness was high, particularly for those with greater HIV acquisition risk, within this Thai MSM cohort, suggesting feasibility of an RM trial. Addressing potential barriers to trial entry may be useful in educational materials to optimize recruitment.

Despite the availability of safe and effective vaccines, little is known about prevalence and risk factors for hepatitis A (HAV) and hepatitis B virus (HBV) infection among Thai men who have sex with men. The prevalence of HAV and HBV infection among men who have sex with men cohort in Bangkok was assessed. Baseline blood specimens were drawn and demographic and behavioral data were collected. Bivariate and multivariate logistic regression analysis was used to analyze risk factors for prevalent HAV and HBV infection. One thousand two hundred ninety-nine Thai men who have sex with men 18 years and older were enrolled. Among those with results, 349/1,291 (27.0%) had evidence of past or current hepatitis A infection. Of the 1,117 (86.5%) men with unambiguous HBV test results, 442 (39.6%) had serologic evidence of past/current infection, 103 (9.2%) were immune due to hepatitis B vaccination, 572 (51.2%) had no evidence of immunological exposure to HBV or vaccine. Of those with past/current HBV infection, 130 (29.4%) were HIV positive. Age >35 years was independently associated with both HAV and HBV infection. University education was protective against both HAV and HBV infection. Increased alcohol consumption, number of lifetime male sexual partners ≥10, and prevalent HIV infection were also independently associated with HBV infection. The prevalence of past/current HAV and HBV infection was high in Bangkok men who have sex with men. Age-cohorts with a higher prevalence of hepatitis B vaccine induced immunity may be expected in the future. Hepatitis A and B vaccination is recommended., (© 2013 WILEY PERIODICALS, INC. This is a US Government work, and, as such, is in the public domain in The United States.)

Objective: To assess HIV-prevalence, incidence and risk factors in a cohort of men who have sex with men (MSM) in Bangkok., Design: : Cohort study with 4-monthly follow-up visits conducted between April 2006 and July 2012 at a dedicated study clinic in a central Bangkok hospital. Participants were 1744 homosexually active Thai men, at least 18 years old and residents of Bangkok., Methods: Men were tested for HIV-infection at every study visit and for sexually transmitted infections at baseline. Demographic and behavioural data were collected by audio-computer-assisted self-interview. Logistic regression analysis was used to evaluate risk factors for HIV-prevalence and Cox proportional hazard analysis to evaluate risk factors for HIV-incidence., Results: Baseline HIV-prevalence was 21.3% (n = 372) and 60 months cumulative HIV-incidence was 23.9% (n = 222). Overall HIV-incidence density was 5.9 per 100 person-years. Multivariate risk factors for HIV-prevalence were older age, secondary/vocational education (vs. university or higher), employed or unemployed (vs. studying), nitrate inhalation, drug use for sexual pleasure, receptive anal intercourse, history of sexual coercion, no prior HIV-testing, and anti-HSV-1 and 2 and Treponema pallidum positivity at baseline. Multivariate risk factors for HIV-incidence were younger age, living alone or with roommate (vs. with a partner or family), drug use for sexual pleasure, inconsistent condom use, receptive anal intercourse, group sex, and anti-HSV-1 and 2 and T. pallidum positivity at baseline. Having no anal intercourse partners was inversely associated with HIV-incidence., Conclusion: The high HIV prevalence and incidence in this cohort of Bangkok MSM documents an explosive epidemic. Additional preventive interventions for MSM are urgently needed.

The potent nonnucleoside reverse transcriptase inhibitor UC781 has been safety tested as a vaginal microbicide gel formulation for prevention of HIV-1 sexual transmission. To investigate whether UC781 retained anti-infective activity following exposure to the female genital tract, we conducted an ex vivo analysis of the UC781 levels and antiviral activity in cervicovaginal lavage (CVL) fluids from 25 Thai women enrolled in a 14-day safety trial of twice-daily vaginal application of two concentrations of the UC781 microbicide gel. CVL samples were collected from women in the 0.1% (n = 5), 0.25% (n = 15), and placebo (n = 5) gel arms following the first application of gel (T(15 min)) and 8 to 24 h after the final application (T(8-24 h)) and separated into cell-free (CVL-s) and pelletable (CVL-p) fractions. As UC781 is highly hydrophobic, there were significantly higher levels of UC781 in the CVL-p samples than in the CVL-s samples for the UC781 gel arms. In T(8-24 h) CVL-p samples, 2/5 and 13/15 samples collected from the 0.1% and 0.25% UC781 gel arms, respectively, efficiently blocked infection with ≥ 4 log(10) 50% tissue culture infective dose (TCID(50)) of a CCR5-tropic CRF01&#95;AE HIV-1 virus stock. Independent of the arm, the 11 CVL-p samples with UC781 levels of ≥ 5 μg/CVL sample reduced infectious HIV by ≥ 4 log(10) TCID(50). Our results suggest that the levels and anti-infective activities of UC781 gel formulations are likely to be associated with a cellular or pelletable component in CVL samples. Therefore, cellular and pelletable fractions should be assayed for drug levels and anti-infective activity in preclinical studies of candidate microbicides.

Background: Few studies of microbicide acceptability among HIV-infected women have been done. We assessed Carraguard® vaginal gel acceptability among participants in a randomized, controlled, crossover safety trial in HIV-infected women in Thailand., Methodology/principal Findings: Participants used each of 3 treatments (Carraguard gel, methylcellulose placebo gel, and no product) for 7 days, were randomized to one of six treatment sequences, and were blinded to the type of gel they received in the two gel-use periods. After both gel-use periods, acceptability was assessed by face-to-face interview. Responses were compared to those of women participating in two previous Carraguard safety studies at the same study site. Sixty women enrolled with a median age of 34 years; 25% were sexually active. Self-reported adherence (98%) and overall satisfaction rating of the gels (87% liked "somewhat" or "very much") were high, and most (77%) considered the volume of gel "just right." For most characteristics, crossover trial participants evaluated the gels more favorably than women in the other two trials, but there were few differences in the desired characteristics of a hypothetical microbicide. Almost half (48%) of crossover trial participants noticed a difference between Carraguard and placebo gels; 33% preferred Carraguard while 12% preferred placebo (p = 0.01)., Conclusions/significance: Daily Carraguard vaginal gel use was highly acceptable in this population of HIV-infected women, who assessed the gels more positively than women in two other trials at the site. This may be attributable to higher perceived need for protection among HIV-infected women, as well as to study design differences. This trial was registered in the U.S. National Institutes of Health clinical trials registry under registration number NCT00213044.

Background: Daily HIV antiretroviral pre-exposure prophylaxis (PrEP) is being evaluated in clinical trials among men who have sex with men (MSM). However, daily PrEP may not be congruent with sexual exposure profiles of MSM. Here, we investigate sex frequency and sex planning to identify and inform appropriate PrEP strategies for MSM., Methods: We evaluated sex frequency and sex planning in a cohort of HIV-negative MSM in Bangkok, Thailand. Chi-squared test was used to compare reports of sex on different weekdays; logistic regression was used to identify predictors of sex frequency and sex planning., Results: Of 823 MSM (with a mean age of 28.3 years), 86% reported having sex on two days per week or less, and 65% reported their last sex to have been planned. Sex on the weekend (approximately 30%) was more often reported than sex on weekdays (approximately 23%). In multivariate analysis, use of alcohol, erectile dysfunction drugs, group sex, sex with a foreigner, buying and selling sex, and a history of HIV testing were associated with having sex on three days or more per week. Being aged 22 to 29 years, not identifying as homosexual, having receptive anal intercourse, and not engaging in group sex were associated with unplanned sex., Conclusions: Intermittently dosed PrEP (as opposed to daily) may be a feasible HIV prevention strategy and should be considered for evaluation in clinical trials. Risk factors for sex frequency and sex planning may help to identify those in need for daily PrEP and those who may not be able to take a timely pre-exposure dose.

Objective: To evaluate the safety, including impact on genital HIV RNA shedding, of Carraguard vaginal gel in HIV-infected women., Design: This is a randomized, controlled, crossover study of Carraguard in HIV-infected women in Thailand., Methods: Each woman (CD4 cell count 51-500 cells/microl and not on antiretroviral therapy) used each treatment (Carraguard, methylcellulose placebo, and no-product) once daily for 7 days during each 1-month period (3-week wash-out). Women were randomized to one of the six possible treatment sequences. Safety assessments were conducted at baseline (pregel), 15 min postgel, day 7, and day 14, and included HIV RNA measurements in cervicovaginal lavage (CVL) specimens., Results: Sixty women were enrolled, and 99% of scheduled study visits were completed. At baseline, median age (34 years), CD4 lymphocyte count (296 cells/microl), plasma HIV viral load (4.6 log10 copies/ml), CVL HIV viral load (3.1 log10 total copies per CVL), and sexual behaviors were similar among randomization groups. HIV viral load, leukocyte and hemoglobin levels, and epithelial cell counts in CVLs were lower 15 min after application of Carraguard or placebo compared with no product; CVL HIV viral load was still lower at day 7 but returned to baseline by day 14. Carraguard use was not associated with prevalent or incident genital findings or abnormal vaginal flora., Conclusion: Carraguard appears to be well tolerated for once-daily vaginal use by HIV-infected women. The observed reduction in CVL HIV viral load in the gel months may be clinically relevant but could have resulted from interference with sample collection by study gels.

Objective: To evaluate extended acceptability of vaginal use of a carrageenan-based candidate microbicide and placebo in northern Thai women., Methods: As part of a randomized, placebo-controlled, triple-blinded clinical trial, women were asked to insert gel with each vaginal sex act and at least three times per week for 1 year. Used applicators were collected monthly; acceptability questions were asked quarterly., Results: One hundred sixty-five women were enrolled (83 microbicide, 82 placebo); 148 (90%) remained in the study for 12 months. Gel use was high, with > or =87% returning at least three used applicators per week at each visit. Although acceptability was generally high, some decline in positive reporting was noted in terms of ease of application, timing of gel insertion, and gel volume over time. Approximately one quarter reported gel use increased her sexual pleasure. Over one quarter reported that gel volume of 5 mL was too much. All women with a steady partner at 12 months reported talking to their partner about using the gel. Only 2 women spontaneously mentioned being able to use a product covertly as one of the most appealing attributes of a potential microbicide., Conclusions: Although women in this study generally reported high acceptability and use, some found 5 mL of gel to be too much. Focusing on enhanced sexual pleasure and lubrication may be beneficial for marketing proven microbicides. Development of products will need to balance lubrication and efficacy with perceptions of too much volume. The ability to use a product covertly was not a high priority in this population.

Background: Candidate vaginal microbicides could cause genital irritation, which in turn could facilitate HIV transmission instead of preventing it. While genital epithelial findings are documented in a standardized manner in most microbicide trials, little is known about background rates and predictors for many types of genital findings., Study Design: A secondary analysis was conducted using data from a Phase II expanded safety study of the candidate microbicide Carraguard gel (Population Council, NY, USA) in Thailand. Genital findings were identified by visual inspection of the cervix, vaginal walls and external genitalia during pelvic exams prior to gel use (screening and enrollment) and during gel use (at 2 weeks and Months 1-12). Women were interviewed about potential risk factors for genital findings at every visit and tested routinely for sexually transmitted and vaginal infections., Results: A total of 258 genital findings were identified in 152 woman-years of follow-up. Genital findings were positively associated with older age, increased parity, self-report of genital symptoms, positive HSV-2 serology, bacterial vaginosis by Nugent scoring and the presence of a genital finding at baseline. Furthermore, vaginal findings were positively associated with vaginal practices and yeast infections. Genital findings were negatively associated with use of hormonal contraception, inconsistently associated with frequency of sex and applicator use, and not associated with condom use., Conclusions: Several factors that are common in women of reproductive age account for the background rate of genital epithelial findings in this population.

Background: Assessment of cervicovaginal cytokine levels may be helpful to evaluate subclinical epithelial inflammation during safety evaluations of candidate microbicides., Methods: Fifty-five HIV-seronegative Thai women were enrolled in a safety trial of the candidate microbicide Carraguard and were randomized to use Carraguard or placebo gel before vaginal sex. Cervicovaginal lavages were collected at baseline and after 1 month of gel use; levels of interleukin (IL)-1beta, IL-6, IL-8, and secretory leukocyte protease inhibitor (SLPI) were measured using microwell plate-based enzyme immunoassays. Median levels were compared between the baseline and 1-month follow-up visits using paired t tests; the median change between groups was compared using Wilcoxon rank sum tests. Women were examined for the presence of genital findings; the association between genital findings and cytokine levels was studied., Results: No increase in levels of proinflammatory cytokines after use of Carraguard gel or placebo gel was observed during the study. The median change from the baseline to 1 month of follow-up was not significantly different between Carraguard and placebo groups (IL-1beta: -0.3 pg/mL vs. -3.93 pg/mL; P = 0.4, IL-6: -0.3 pg/mL vs. 0 pg/mL; P = 0.3, IL-8: -40.1 pg/mL vs. -53.2 pg/mL; P = 0.8, and SLPI: -26.5 pg/mL vs. 12.6 pg/mL; P = 0.07). Genital findings with intact epithelium were found in 16 (29%) women; these women tended to have somewhat higher IL-6 levels than those with normal epithelium (14.9 pg/mL vs. 8.8 pg/mL; P = 0.08)., Conclusion: We found no increase in proinflammatory cytokines after Carraguard and placebo gel use, suggesting that neither gel causes inflammation. Further studies to assess the role of cytokines in microbicide safety studies are warranted.

In northern Thailand, where substantial male-to-female transmission of HIV has occurred in stable partnerships, the relationships between counseling, communication, and HIV-preventive behaviors in married couples have not been well studied. In a study of HIV incidence among women in northern Thailand, each participant was advised to learn her husband's HIV-infection status and was asked to bring him for an interview at the final 12-month follow-up visit. Of the 337 men interviewed, 58% reported having ever had an HIV test. More men reported testing following their wives' enrollment: 12% in the year prior to enrollment vs 22% during the 1-year study (p < 0.001). In the univariate analysis, men's HIV testing during the 6 months before being interviewed was associated with communication about HIV testing with their wife and extra marital sex with non-FSW while married. Testing following their wife's request was the most common reason reported. Agreement between husband's and wife's reports was poor for most issues, such as whether HIV-related communication had occurred, but agreement as to whether the husband had ever been tested for HIV was relatively high (kappa = 0.62). However, in the logistic regression analysis, only sex with non-FSW while married remained associated with HIV testing (p = 0.02). The results suggest a relationship between counseling, communication, and husband HIV testing. Better communication by couples may result in more effective use of HIV testing, which is already prevalent in this population, to prevent HIV transmission.

Objectives: To evaluate the acceptability of candidate microbicide Carraguard among couples participating in a safety trial., Study Design: A 6-month randomized, placebo-controlled trial was conducted in sexually active, low-risk couples in Thailand., Methods: Couples who were monogamous, HIV uninfected, and not regular condom users were enrolled. Acceptability data were collected through structured questionnaires at repeated intervals. At the closing study visit, participants were asked questions about hypothetical product characteristics and future use. Compliance with gel use was assessed by questionnaires, coital diaries, and tracking of used and unused applicators., Results: Among 55 enrolled couples, follow up and adherence with gel use were high and sustained, with 80% of women using gel in over 95% of vaginal sex acts. Because acceptability results from Carraguard and placebo arms were similar, they were combined for this analysis. Overall, 92% of women and 83% of men liked the gel somewhat or very much; 66% of women and 72% of men reported increased sexual pleasure with gel use; and 55% of women and 62% of men reported increased frequency of intercourse. Only 15% of women but 43% of men thought that gel could be used without the man knowing. Although men and women had similar views overall, concordance within couples was low, with no kappa coefficients above 0.31., Conclusion: Carraguard gel use was acceptable to low-risk couples in northern Thailand. Reported associations between gel use and increased sexual pleasure and frequency suggest a potential to market microbicide products for both disease prevention and enhancement of pleasure.

Objective: To determine the safety and acceptability of vaginal application of Carraguard, a carrageenan-derived candidate microbicide gel., Design: A randomized, placebo-controlled, triple-blinded clinical trial was conducted in Chiang Rai, northern Thailand., Methods: Women were asked to insert one applicator of study gel vaginally at least three times per week (with or without sex) and to use gel with condoms every time they had sex. Safety was assessed by visual inspection of the vagina and cervix, changes in vaginal flora and self-reported symptoms at day 14, month 1 and then monthly for up to 1 year. Acceptability was assessed through reported use of the gel, return of used and unused applicators, and quarterly interviews., Results: One hundred sixty-five women were randomized: 83 to Carraguard and 82 to the placebo (methylcellulose gel) group. Study gel use was similarly high in both groups throughout the trial with an average of four applicators per week. Carraguard use was not associated with abnormal genital clinical findings, abnormal vaginal flora, Pap smear abnormalities or other abnormal clinical signs or symptoms. Adverse events were mostly mild, not attributed to gel use, and similarly distributed between groups. Participants in both groups reported high acceptability., Conclusions: Carraguard can safely be used an average of four times per week with or without sex and is acceptable to Thai women. A Phase III efficacy trial of Carraguard is warranted and is currently ongoing in South Africa.

Palmtop-assisted self-interviewing (PASI) may provide a cheaper and more mobile alternative to audio-computer-assisted self-interviewing (ACASI) for collecting sensitive behavioral data. To evaluate PASI, in late 2002 the authors enrolled 1,283 Thai students aged 15-21 years in a randomized trial. Data collection used PASI, ACASI, self-administered questionnaire, and face-to-face interview in combination with drug-use urine testing. By use of reported levels of behaviors and agreement between self-reports of smoking and urine test results, PASI and ACASI (alpha = 0.05) were compared for noninferiority, and PASI and interview were compared for superiority (alpha = 0.05). Noninferiority of PASI was demonstrated by use of self-reports of the most sensitive areas of sexual behavior (e.g., oral sex, sexual intercourse, commercial sex, history of genital ulcers, pregnancy), as well as self-reports of less sensitive behaviors (e.g., alcohol use, dietary behaviors, symptoms of depression). Data generally showed noninferiority of PASI, ACASI, and self-administered questionnaires when compared with each other and superiority of PASI, ACASI, and self-administered questionnaires when compared with interviews. PASI agreements between self-reports of tobacco smoking and presence of nicotine metabolites in urine were noninferior to ACASI and superior to interviews. The establishment of PASI noninferiority and superiority using behavioral and biologic measures suggests that PASI is a scientifically acceptable alternative for collecting sensitive behavioral data.

Unplanned pregnancy among young people can lead to adverse social, psychological, and health outcomes, particularly when it results in abortion. In 1999, we examined the prevalence of and factors associated with pregnancy and abortion among 1725 consenting vocational school students in northern Thailand. Results from an audio computer-assisted self-interview showed that 48% of the male and 43% of the female students reported ever having had sexual intercourse. Among those who had had intercourse, 27% of the women and 17% of the men said they or their partner had ever been pregnant. Among the last reported pregnancies that resulted in delivery or abortion, 95% were aborted. Age, current contraceptive use, early initiation of sexual intercourse (

To investigate knowledge and perceptions of HIV transmission risk and interest in vaginal microbicides in northern Thailand, we conducted 14 focus group discussions and 80 interviews with men and women in Chiang Rai province. Women were recruited from antenatal or postpartum clinics, and men from various work sites. Participants evinced substantial knowledge about HIV, with two exceptions important for prevention campaigns: (a) confusion about the window period between a new infection and positive HIV-test result and (b) overestimation of the safety of extramarital sex with partners who are not sex workers. Most participants reported no personal HIV risk. Participants described Thai women as generally vulnerable to HIV infection because of the unlikelihood of condom use with their husbands and because women cannot control their husbands' extramarital behavior. Women apparently face particular risk after childbearing; peripartum abstinence averages 6-9 months, during which time some Thai men may have alternative sex partners. Women, and to a lesser degree, men were interested in potential microbicides, although they voiced many thoughtful questions about the products and about efficacy trials.

Sexual coercion was assessed in a cross-sectional survey of drug use and sexual behavior in vocational school students from Chiang Rai, Thailand (n = 1725; ages 15-21), using audio-computer assisted self-interview. Sexual coercion was reported by 6.5% of males and 21% of females. Mean age at first occurrence was 16 years (range 8-20) among males and 17 years (range 5-21) among females. Most perpetrators were male (52% among males; 98% among females) and known by the participants. Among females, associated factors were history of pregnancy, selling sex, marijuana use, perceived risk of STD, two or more lifetime sexual partners, and living away from family. Among males, associated factors were homo- or bisexual self-identification, parents living together, and ulcerative STD history.

Although use of rapid HIV antibody tests of finger-stick blood specimens could expand voluntary counseling and testing in areas where fear of venipuncture and delays in learning test results are barriers, there is little information on performance and acceptability of these tests in Asia. We used the Hema. Strip HIV-1/2 test (Saliva Diagnostic Systems, Vancouver, WA) in a prospective cohort study of HIV seroincidence among women in northern Thailand from 1998 to 1999. Nurses obtained whole-blood specimens by finger-stick testing and provided test results and counseling at each visit. Acceptability of the rapid test was assessed at the first 6-month follow-up visit. HIV-1 seroprevalence among the 804 women screened at enrollment was 3.1%. Positive rapid test results from 25 women were confirmed by enzyme immunoassay and Western blot analysis using serum obtained by venipuncture. Of the 741 women who returned for follow-up, 56% preferred specimen collection by finger-stick testing to venipuncture, 80% preferred immediate rather than delayed test results, 79% preferred the rapid test method to typical testing methods, and 97% were satisfied with the test method used. Results from this study demonstrate the utility and acceptability of the rapid finger-stick test for HIV antibody among women in northern Thailand.

Aims: Data from drug treatment facilities, drug seizures and drug arrests suggest rapidly increasing methamphetamine use by adolescents in Thailand. However, limited quantitative data are available about the prevalence of its use or correlates of use. The purpose of our study was therefore to estimate the prevalence of methamphetamine use and to identify possible risk factors., Design: Cross-sectional survey using anonymous audio-computer-assisted self-interview and urine specimen analysis., Setting: Chiang Rai Province, Thailand., Participants: 1725 students, 15-21 years of age (893 male and 832 female) attending one of three vocational schools in Chiang Rai Province., Findings: Three hundred and fifty male and 150 female students reported a history of having ever used methamphetamine. In addition, 128 male and 49 female students had positive urine test results, indicating recent methamphetamine use; 27 of these students denied having ever used methamphetamine. According to history, urine test, or both, 41.3% of male students and 19.0% of female students used methamphetamine. In multivariate analysis, methamphetamine use was highly correlated with the use of other substances, sexual activity, peer pressure, positive attitudes toward methamphetamine, and absence of a family confidant., Conclusions: Methamphetamine use is common among adolescent students in northern Thailand. Demographic, behavioral and psychosocial correlates of methamphetamine use identified in this study may be helpful for the design and implementation of preventive interventions.

To determine the incidence of and risk factors for HIV-1 infection among married women in northern Thailand, we enrolled 779 seronegative women from family planning clinics and a postpartum ward in Chiang Rai, Thailand, from 1998 through 1999. Women were tested for HIV antibodies at 6 and 12 months after enrollment. They received HIV prevention counseling at enrollment and at each follow-up visit. Counseling covered partner communication, partner HIV testing, and condom use by steady partners. Effects of counseling were measured using standardized questionnaires. Follow-up rates were 94% at 6 months and 92% at 12 months. Only 1 woman seroconverted during the follow-up period, yielding an overall HIV incidence of 0.14 per 100 person-years. After receiving counseling, women reported significantly increased communication with husbands concerning HIV risk, HIV testing, and condom use during the first 6 months after enrollment; communication remained high for 6 to 12 months. Women reported a modest increase in HIV testing and consistent condom use by husbands. The risk for HIV transmission to women in steady relationships is low in northern Thailand. Although HIV prevention counseling promoted partner communication, its effects on HIV preventive behaviors were limited.

To assess women's interests and concerns regarding participation in trials of microbicides in Chiang Rai, Thailand, we administered structured questionnaires. Before answering the questionnaire, women attended an educational session on microbicides and clinical trials. Of 370 participants, 82% correctly answered 8 or more of the 11 overall comprehension questions, indicating an adequate knowledge base among the women from which to answer questions about attitudes toward microbicide trials. The most common motivations for participating in a trial were "getting tested for HIV" and "doing something good for women's health." The greatest barrier to participation was women's fear that if they proposed use of a microbicide, their husbands might feel protected and thereby have more sex partners. Overall, 6.2% said they would be "definitely willing to participate," and 66.8% said they wanted to participate but wanted to think about it. Most women previously unacquainted with the concept of microbicides or clinical trial design displayed adequate knowledge of these subjects after the short educational session. If women's initial reactions are validated by actual willingness, surveys could prove valuable for selecting sites for microbicide trials, estimating enrollment rates, and tailoring trials to make them most acceptable to women.

From July 1983 to March 1984 a randomized double blind prophylactic trial in Thai gem miners working across the border in Cambodia was conducted to determine the prophylactic efficacy of 3 drug regimens against P. falciparum and P. vivax malaria along the Thai-Cambodian border. Gem miners have a high incidence of malaria. Maximum duration of individual participation was 14 weeks. Of 334 participants in this study who were seen every 2 weeks, 145 received mefloquine 500 mg fortnightly, 112 received chloroquine 300 mg base weekly plus Fansidar (1000 mg sulfadoxine and 50 mg pyrimethamine) fortnightly and 77 received chloroquine as 300 mg base weekly. The significant reduction of vivax malaria in study subjects (compared to background incidence) implied good compliance with self administration of chloroquine in the intervening weeks between scheduled appointments. The attack rate in each prophylactic regimen was 2188 cases/1000/year with mefloquine, 8338 cases/1000/year with chloroquine-Fansidar and 10,207 cases/1000/year receiving chloroquine alone. There was a 79% prophylactic efficacy for mefloquine and 18% efficacy for the chloroquine plus Fansidar regimen compared to chloroquine. Using life table analysis, 56% of the mefloquine group, 6% of the chloroquine-Fansidar group and 4% of the chloroquine group were malaria free at the end of the 14 weeks study. The chloroquine plus sulfadoxine-pyrimethamine regimen prescribed for prophylaxis is no longer effective for multidrug resistant strains of P. falciparum in the study area. This study also seriously questions the efficacy of mefloquine prophylaxis.